Societal™ CDMO

Societal™ CDMO is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.

In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

Societal CDMO: Bringing Science to Society. For more information about Societal CDMO’s customer solutions, visit societalcdmo.com.

Innovative Reformulation of a Complex, High-Drug-Load, Modified Release Dosage Form With Reduced Dosing Frequency

The FDA wants you to reformulate your opioid oral controlled-release product to provide a level of abuse deterrence. A lengthy, expensive ordeal seems inevitable. But what if you could limit and position the formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance? We helped a client in exactly this position accomplish a complex reformulation and successful CMC supplement filing in less than a year. Learn more by downloading this case study.
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How to Achieve Different Release Profiles and Select Excipients for Formulation Development of Modified Release Oral Solid Dosage Forms

In pharmaceutical manufacturing, the formulation and manufacture of modified-release oral solid dosage forms are highly specialized. A holistic approach is necessary to obtain the desired release profile(s). This paper details numerous considerations for the planning and executing of a successful modified release oral solid dosage formulation.
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How to Avoid Last Minute CMC Roadblocks to Approval

It’s tempting to minimize or defer CMC activities while preparing for clinical milestones. Are you making decisions that may delay — rather than accelerate — development? Steer clear of: “We have to start over” by reading this white paper.
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Is Wurster Processing the Right Choice for My Multiparticulate Modified Release Dosage Form?

Wurster processing is a versatile pharmaceutical development and manufacturing technique for multiparticulates in modified release (e.g., extended or controlled release) dosage forms. Learn how to tell it’s the right method for your modified-release project by reading this white paper.
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